Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
United States12 participantsStarted 2018-05-07
Plain-language summary
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect and there is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. To the best of the investigator's knowledge, this is the first study to evaluate the safety of intra-lesional injections of nivolumab in patients with KS.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. For screening: Participants must have histologically confirmed KS with active cutaneous disease and have less than 25 lesions. For enrollment: Participants must have histologically confirmed KS in the research skin biopsy performed during the screening visit.
â. Participants must have measurable cutaneous KS disease, defined as 1 or more marker lesion that is bi-dimensionally measurable, and \>=0.5cm in shortest dimension. These measurable lesions must not have received previous local radiation, surgical, or intralesional cytotoxic therapy that would prevent response assessment. Note: Participants may eligible even if some KS lesions that have previously been treated with local therapy, as long as other untreated KS lesions are measurable as defined in the protocol.
â. For the initial safety cohort (cohort A), participants have to be treatment-experienced, i.e. at least one of the KS skin lesions has been persisted despite having been treated with:
â. Age \>= 18 years.
â. If human immunodeficiency virus (HIV)-infected, participants must have:
â. If HIV-uninfected, participants must have documentation of a negative HIV result by any federally approved, licensed HIV test within the last 12 months.
â. Adequate organ function defined as follows:
â
What they're measuring
1
Number participants with Dose Limiting Toxicities (DLT) (Cohort A)
â. Prior systemic KS-directed treatments or investigational modalities \<= 5 half-lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy to grade 1 or less.
â. Presence of any visceral KS (including KS-associated lymphedema) requiring systemic chemotherapy. This includes, but not limited to, any symptomatic visceral KS or asymptomatic pulmonary KS.
â. Hypersensitivity to nivolumab or any of its excipients.
â. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
â. Opportunistic infection within the last 3 months.
â. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
â. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. This does not apply to participants in the extension cohort (cohort B-plus).